Hacettepe University Faculty of Physical Therapy and Rehabilitation
Ankara, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07839689
The goal of this clinical trial is to learn if aerobic exercise training and connective tissue massage, in addition to patient education, can help treat women with bladder pain syndrome. The main questions it aims to answer are:
Does aerobic exercise training and connective tissue massage reduce bladder-related pain severity?
Does this intervention improve urinary symptoms, pain sensitivity, central sensitization-related symptoms, psychological symptoms, and quality of life?
Researchers will compare patient education plus aerobic exercise training and connective tissue massage with patient education alone to see if the combined physiotherapy program is more effective.
Participants will:
Receive patient education about bladder pain syndrome
Be randomly assigned to one of two groups
Receive either patient education alone or patient education together with aerobic exercise training and connective tissue massage for 8 weeks
Complete assessments at the beginning of the study and after 8 weeks
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Ankara, Turkey (Türkiye)
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive patient education about bladder pain syndrome, symptom management, lifestyle recommendations, and strategies to support self-management. This intervention will be provided to both study groups.
Participants in the intervention group will receive an 8-week aerobic exercise training program in addition to patient education.
Participants in the intervention group will receive connective tissue massage in addition to patient education and aerobic exercise training. The intervention will be delivered by a physiotherapist according to the study protocol as part of the 8-week multimodal physiotherapy program.
Time frame: Baseline and 8 weeks
Bladder-related pain severity will be assessed using a 10-cm Visual Analog Scale. Participants will be asked to mark the point that best represents the most severe bladder-related pain or pain-like discomfort, such as burning, pressure, or discomfort, experienced during the last three days. Scores range from 0 to 10, with higher scores indicating greater pain severity.
Time frame: Baseline and 8 weeks
Bladder pain syndrome-related symptom severity will be assessed using the Interstitial Cystitis Symptom Index. The index consists of 4 items assessing urinary urgency, urinary frequency, nocturia, and bladder pain or burning. Total scores range from 0 to 20, with higher scores indicating greater bladder pain syndrome-related symptom severity.
Time frame: Baseline and 8 weeks
Bladder pain syndrome-related problem severity will be assessed using the Interstitial Cystitis Problem Index. The index consists of 4 items assessing the extent to which urinary frequency, nocturia, urinary urgency, and bladder pain or burning are experienced as problems. Total scores range from 0 to 16, with higher scores indicating greater bladder pain syndrome-related problem severity.
Time frame: Baseline and 8 weeks
Pressure pain threshold will be assessed using a digital pressure algometer over the suprapubic region, peroneal region, and ulnar surface of the forearm. The value at which the participant first perceives the applied pressure as painful will be recorded. Three measurements will be taken from each site.
Time frame: Baseline and 8 weeks
Conditioned pain modulation will be assessed using pressure pain threshold measurement over the upper trapezius muscle as the test stimulus and a cuff pressure test applied to the contralateral upper extremity as the conditioning stimulus. Pressure pain threshold will be measured before and immediately after the conditioning stimulus.
Time frame: Baseline and 8 weeks
Central sensitization-related symptoms will be assessed using the Central Sensitization Inventory. The scale includes 25 items related to symptoms such as pain, fatigue, sleep disturbance, cognitive complaints, and emotional symptoms. Total scores range from 0 to 100, with higher scores indicating greater central sensitization-related symptom burden.
Time frame: Baseline and 8 weeks
Anxiety and depression symptoms will be assessed using the Hospital Anxiety and Depression Scale. The scale consists of 14 items and includes two 7-item subscales evaluating anxiety and depression. Scores for each subscale range from 0 to 21, with higher scores indicating greater anxiety or depression symptom severity.
Time frame: Baseline and 8 weeks
Functional exercise capacity will be assessed using the 6-Minute Walk Test. Participants will be asked to walk as far as possible without running for 6 minutes in a suitable corridor. The total distance walked will be recorded in meters.
Time frame: Baseline and 8 weeks
Health-related quality of life will be assessed using the 12-Item Short Form Health Survey. The questionnaire yields Physical Component Summary and Mental Component Summary scores. Each score ranges from 0 to 100, with higher scores indicating better physical or mental health-related quality of life.
Time frame: At 8 weeks
Participants' perceived change in bladder-related pain symptoms compared with the beginning of treatment will be assessed using a 7-point subjective perception of change scale. Scores range from 1 to 7, where 1 indicates markedly worse, 4 indicates no change, and 7 indicates markedly improved. Higher scores indicate greater perceived improvement.
Time frame: During the 8-week intervention period
Adherence to the intervention will be assessed based on attendance at clinical sessions and continuation of out-of-clinic aerobic exercises. Attendance at clinical sessions will be recorded after each session. Adherence to out-of-clinic aerobic exercises will be monitored using exercise diaries kept by participants and the physiotherapist, and adherence will be calculated as a percentage.
Time frame: At 8 weeks
Adherence to lifestyle recommendations will be assessed using a Numeric Rating Scale. Participants will be asked to rate their overall adherence to the lifestyle recommendations on a scale from 0 to 10, where 0 indicates no adherence and 10 indicates complete adherence.
Interested in participating?
Request InfoHacettepe University
Other
Effects of Aerobic Exercise Training and Connective Tissue Massage in Individuals With Bladder Pain Syndrome
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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